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Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood

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ClinicalTrials.gov Identifier: NCT03917706
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Pierre Wauthy, Brugmann University Hospital

Brief Summary:

The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases. However, there are specific social and psychological troubles that appear later in life and can compromise employability, insurability and social integration.

There are different types of congenital heart disease: those not operated in adulthood, and those operated for curative or palliative purposes. It is estimated that about 10 out of 1000 babies are born with a congenital cardiac malformation. One-third of these have a critical diagnosis requiring a surgical intervention.

Data from the literature show that there is an unusually high prevalence of psychosocial, neurological, developmental and psychiatric disabilities among survivors, as they enter formal education.There are many factors that influence developmental outcomes at school age. Early intervention is an essential element in controlling these comorbidities. The continuous monitoring of the development by a multidisciplinary team would make it possible to identify a developmental disorder as soon as it appears and respond to it as quickly as possible.For many children and their families, the burden of the developmental consequences is higher than the daily impact of the heart disease.

Most studies and measures of quality of life in congenital heart patients require methodological improvements.They contribute little to the scientific basis of the quality of life in these patients. Future quality of life studies must invest in rigorous conceptualization, adequate operational definition and a good measure of quality of life.

The investigators propose to develop a reproducible and reliable quality of life measurement tool, suitable for adult patients suffering from congenital heart disease and having had surgery during childhood.


Condition or disease Intervention/treatment
Congenital Heart Disease Other: Questionnaire

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort Intervention/treatment
Congenital Heart Disease
Adults suffering from congenital heart disease, followed within the CHU Brugmann hospital, operated during childhood.
Other: Questionnaire
Patients will be contacted by phone in order to fill in a questionnaire regarding their quality of life.




Primary Outcome Measures :
  1. Quality of life assessment [ Time Frame: 30 minutes ]
    Quality of life will be assessed by means of a questionnaire adapted to adult patients suffering from congenital cardiopathy and having had surgery during childhood. There are 76 short closed questions, about 6 different domains (physical activity, social life, family life, professional life, scholarity, psychological comfort).


Secondary Outcome Measures :
  1. Medical antecedents [ Time Frame: 30 minutes ]
    List of medical antecedents of the patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults suffering from congenital heart disease, having had surgery during childhood, followed within the CHU Brugmann Hospital.
Criteria

Inclusion Criteria:

  • congenital heart disease,
  • patients having had surgery during childhood,
  • patients followed within the CHU Brugmann Hospital.

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917706


Contacts
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Contact: Marine DENEUBOURG, MD 3224773995 evaluationqualitedevie@gmail.com
Contact: Pierre Wauthy, MD 3224773995 Pierre.Wauthy@chu-brugmann.be

Locations
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Belgium
CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Pierre Wauthy, MD         
Sponsors and Collaborators
Pierre Wauthy
Investigators
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Principal Investigator: Marine DENEUBOURG, MD CHU Brugmann

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Responsible Party: Pierre Wauthy, Medical Director of the CHU Brugmann Hospital, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03917706     History of Changes
Other Study ID Numbers: CHUB-congenital cardiopathy
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities